(294 days)
No
The summary describes a mechanical device for limb lengthening and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for limb lengthening of the femur and tibia, which is a therapeutic intervention to correct a medical condition.
No
The device is described as a "modular implantable intramedullary rod, locking screws, and an external actuator" used for limb lengthening. Its function is to physically lengthen bones, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is composed of a modular implantable intramedullary rod, locking screws, and an external actuator, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "limb lengthening of the femur and tibia." This is a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Device Description: The device is an "implantable intramedullary rod, locking screws, and an external actuator." These are physical devices used to mechanically lengthen bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic purpose (limb lengthening).
N/A
Intended Use / Indications for Use
The NOVOS-NAIL Limb Lengthening System is indicated for limb lengthening of the femur and tibia.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Smith & Nephew NOVOS-NAIL Limb Lengthening System (NOVOS-NAIL LLS) is composed of a modular implantable intramedullary rod, locking screws, and an external actuator. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. The system uses locking screws and nail caps (optional) previously cleared with the TRIGEN Nail system (K981529).
The NOVOS-NAIL implant includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The subject device is supplied sterile by gamma sterilization. The external actuator is supplied non sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Femur and tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Finite Element Analysis (FEA) FEA of the 8mm and 11mm NOVOS Limb . Lengthening Nails using Retrograde Femoral and Antegrade Tibial Loading Modes- Finite Element analysis evaluated the structural strength of the subject devices in retrograde femur and antegrade tiba loading configurations.
- Construct Fatigue Testing- Construct fatigue testing was conducted on the ● 8mm and 11mm NOVOS-NAIL and the predicate device. Results of the testing have determined that the subject devices would have equivalent construct fatigue performance compared to the predicate.
- . Bending Fatigue Evaluation- Testing was conducted to evaluate the bending fatigue performance of the 8mm and 11mm NOVOS- NAIL and to determine potential failure modes for the nail. Results of the testing have determined that the subject devices would have similar bending fatigue performance as compared to the predicate.
- . Distraction Accuracy-Testing evaluating the accuracy of the actuator and the distraction mechanism in the NOVOS-NAIL was conducted for both the 8mm and 11mm nail. Results of the testing have shown the subject devices have met the acceptance criteria for distraction accuracy.
- Usability Testing- A human factors validation was conducted to evaluate the usability of the NOVOS-NAIL LLS. Results of the usability study have shown that any residual use-related risk that remain after human factors testing are low and are outweighed by the benefits derived from the device.
- Bacterial Endotoxin Testing: Testing was completed and found to have the . met the acceptable endotoxin limits as stated in the FDA Guidance, " Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," and "Pyrogen and Endotoxin Testing: Questions and Answers," and ANSI/AAMI ST72.
- Static Bend Strength: Testing was conducted to evaluate the static bend . performance of the 8mm and 11mm NOVOS-NAIL in a static three point bend test. Results of the testing have shown the subject devices demonstrate adequate static bending performance during the expected clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
October 13, 2017
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Smith & Nephew Allison Chan Regulatory Affairs Specialist II 1450 E Brooks Rd. Memphis, Tennessee 38116
Re: K163653
Trade/Device Name: NOVOS-NAIL Limb Lengthening System (LLS) Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: September 22, 2017 Received: September 25, 2017
Dear Allison Chan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 | ||
|---|---|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 | ||
| Indications for Use | See PRA Statement below. | ||
| 510(k) Number (if known) | K163653 | ||
| Device Name | NOVOS-NAIL Limb Lengthening System | ||
| Indications for Use (Describe) | The NOVOS-NAIL Limb Lengthening System is indicated for limb lengthening of the femur and tibia. | ||
| Type of Use (Select one or both, as applicable) | |||
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image contains the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray. To the right of that, the text "smith&nephew" is written in orange.
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 10,2017 |
| Contact Person and Address: | Allison Chan
Regulatory Affairs Specialist II
T 901-399-1098
F 901-566-7022 |
| Name of Device: | Smith & Nephew, Inc. NOVOS-NAIL Limb Lengthening
System |
| Common Name: | Intramedullary Nail |
| Device Classification Name and
Reference: | 21 CFR 888.3020, Intramedullary fixation rod |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | HSB (Rod, Fixation, Intramedullary and Accessories) |
Device Description
The Smith & Nephew NOVOS-NAIL Limb Lengthening System (NOVOS-NAIL LLS) is composed of a modular implantable intramedullary rod, locking screws, and an external actuator. The modular implantable rod is available in different configurations, lengths, and diameters to accommodate a variety of patient anatomies. The system uses locking screws and nail caps (optional) previously cleared with the TRIGEN Nail system (K981529).
The NOVOS-NAIL implant includes an enclosed rare earth magnet, telescoping lead screw/nut assembly and gearing. The subject device is supplied sterile by gamma sterilization. The external actuator is supplied non sterile.
Intended Use
The NOVOS-NAIL Limb Lengthening System is indicated for limb lengthening of the femur and tibia.
4
Comparison of Technology Characteristics with the Predicate Device
The NOVOS-NAIL Limb Lengthening System is substantially equivalent in design and fundamental scientific technology to the defined predicate and does not raise any new issues of safety and efficacy. At a high level, the subject and predicate devices are based on the following same technological elements
- Limb lengthening for tibia and femurs
- Implanted in the intramedullary canal .
The following technological differences exist between the subject and predicate device.
- . Ability to shorten nail if the rod has been distracted too far
- Use of external device to control interaction of rare earth magnet ●
- o Manufactured from 20Cr-15Ni-40Co-7Mo-16Fe
Summary of Pre-Clinical Testing
The following performance data was provided in support of the substantial equivalence determination:
- Finite Element Analysis (FEA) FEA of the 8mm and 11mm NOVOS Limb . Lengthening Nails using Retrograde Femoral and Antegrade Tibial Loading Modes- Finite Element analysis evaluated the structural strength of the subject devices in retrograde femur and antegrade tiba loading configurations.
- Construct Fatigue Testing- Construct fatigue testing was conducted on the ● 8mm and 11mm NOVOS-NAIL and the predicate device. Results of the testing have determined that the subject devices would have equivalent construct fatigue performance compared to the predicate.
- . Bending Fatigue Evaluation- Testing was conducted to evaluate the bending fatigue performance of the 8mm and 11mm NOVOS- NAIL and to determine potential failure modes for the nail. Results of the testing have determined that the subject devices would have similar bending fatigue performance as compared to the predicate.
- . Distraction Accuracy-Testing evaluating the accuracy of the actuator and the distraction mechanism in the NOVOS-NAIL was conducted for both the 8mm and 11mm nail. Results of the testing have shown the subject devices have met the acceptance criteria for distraction accuracy.
- Usability Testing- A human factors validation was conducted to evaluate the usability of the NOVOS-NAIL LLS. Results of the usability study have shown that any residual use-related risk that remain after human factors testing are low and are outweighed by the benefits derived from the device.
- Bacterial Endotoxin Testing: Testing was completed and found to have the . met the acceptable endotoxin limits as stated in the FDA Guidance, " Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," and "Pyrogen and Endotoxin Testing: Questions and Answers," and ANSI/AAMI ST72.
- Static Bend Strength: Testing was conducted to evaluate the static bend . performance of the 8mm and 11mm NOVOS-NAIL in a static three point bend test. Results of the testing have shown the subject devices demonstrate adequate static bending performance during the expected clinical use.
5
Substantial Equivalence Information
The substantial equivalence of the NOVOS-NAIL Limb Lengthening Nail System is based on similarities in intended use, indications for use, overall design, and performance to the predicate systems listed in the following table.
Table 5.1: Substantially Equivalent Predicates to the NOVOS Limb Lengthening Nail System
| Design
Aspect
Reviewed | NOVOS-NAIL Limb
Lengthening Nail System | Intramedullary
Skeletal
Kinetic
Distractor
(ISKD)-Primary
Predicate | Precice
Intramedullary
Limb
Lengthening
System-
Reference
Predicate |
|-----------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| 510(k)
Number | Subject 510(k) | K010322 | K101997 |
| Manufacturer | Smith & Nephew | OrthoDyne,
Inc. | Ellipse
Technologies, Inc. |
| Similar
Indications
for Use | Yes | Yes | Yes |
| Sterilization
Methods | Gamma | Ethylene Oxide | Gamma |
| Nail
Diameter | 8mm, 11mm | 10.7mm | 8.5mm, 10.7mm,
and 12.5mm |
| Cross
Section
Shape | Circular | Circular | Circular |
| Rate of
Lengthening | Physician to determine rate.
Dependent upon patient
activity level;
1mm/day | Physician to
determine rate.
Dependent
upon patient
activity
level; .75-
1.25mm/day | Physician to
determine rate,
dependent upon
patient activity
level ~1mm /day. |
| Control of
Lengthening | External Actuator | Patient's
activity level,
l.e. rotational
oscillations of
the limb | External remote
controller |
| Monitoring
of
Distraction | X-ray for confirmation | External hand
held monitor | X-ray for
confirmation |
6
| Design
Aspect
Reviewed | NOVOS-NAIL Limb
Lengthening Nail System | Intramedullary
Skeletal
Kinetic
Distractor
(ISKD)-Primary
Predicate | Precice
Intramedullary
Limb
Lengthening
System-
Reference
Predicate |
|------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Safety
Features | Length of rod is able to be
shortened by rotating the
external actuator | Automatic stop
when
predetermine
length is
achieved; one-
way clutch
design | Length of rod is
able to be
shortened from
the external
remote controller |
| Material | 20Cr-15Ni-40Co-7Mo-16Fe | Ti-6Al-4V | Ti-6Al-4V |
| Method of
Fixation | 4.5mm & 5.0mm Internal Hex
Captured Screws (K981529) | 4.0mm &
4.8mm
diameter
locking screws | Locking Pegs |
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the NOVOS-NAIL Limb Lengthening Nail System. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to above predicate systems.